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Clinical efficacy and safety evaluation The primary outcome was the number of treatment sessions required to reach the predefined treatment endpoint

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Updated FDA guidance formally supported decentralized trial elements such as telehealth visits, remote monitoring, and home-based procedures, reinforcing these approaches as durable infrastructure rather than temporary workarounds

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We are hoping to have an update on that conversation with the FDA before the end of this year, said Maggie Pfieffer, a spokesperson for Lilly's diabetes program